Digital Therapy Device For Amblyopia
The Digital Therapy Device for Amblyopia is an ophthalmic device that incorporates dichoptic visual presentations on displays through therapeutic algorithms to treat amblyopia (lazy eye) or to improve visual acuity in patients with amblyopia, providing a digital alternative or complement to traditional patching therapy. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 886.5500 in the Ophthalmic specialty. It carries product code QQU and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QQU
- Device Class
- FDA class 2
- Regulation Number
- 886.5500
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243819 | Luminopia | Apr 09, 2025 | Substantially Equivalent | Luminopia, Inc. |
| K233720 | Luminopia | Aug 08, 2024 | Substantially Equivalent | Luminopia, Inc. |
| K221659 | Luminopia One | Nov 04, 2022 | Substantially Equivalent | Luminopia, Inc. |
| K221375 | CureSight-CS100 | Sep 29, 2022 | Substantially Equivalent | Novasight , Ltd. |
| DEN210005 | Luminopia One | Oct 20, 2021 | Unknown | Luminopia, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.